Infrapopliteal artery stenosis or occlusion
Conditions
Interventions
Experimental group:Drug eluting subknee balloon dilator catheter
Control group:Subgenular drug-coated balloon dilation catheter
Sponsors
Xuanwu Hospital of Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or non-pregnant women aged 18-85 years; 2. Primary atherosclerotic stenosis or occlusion of the infrapopliteal artery (from P2 segment of the popliteal artery to above the ankle); 3. Indications for percutaneous endovascular treatment, and the degree of occlusion or stenosis of the target lesion vessel is >=70%; 4. Rutherford grade 3-6; 5. The total length of single vessel target lesion =50% stenosis in the ipsilateral inflow tract confirmed by DSA or CTA; 8. The reference vessel diameter of target lesion was 2.0-4.0 mm; 9. Patients or their guardians understood the purpose of the trial, volunteered to participate, provided written informed consent, and were available for follow-up.
Exclusion criteria
Exclusion criteria: 1. Pregnant women; 2. Primitive submalleolar lesions; 3. Patients who have had or are planning a major amputation; 4. Life expectancy <1 year; 5. History of stroke or myocardial infarction within 3 months before surgery; 6. Severe renal insufficiency with serum creatinine more than 2 times the upper limit of normal; 7. Patients with acute thrombosis requiring thrombolysis or thrombectomy; 8. Patients requiring simultaneous intervention of both lower limbs; 9. Known allergy or intolerance to rapamycin, paclitaxel, contrast media, or antiplatelet drugs; 10. Patients with previous history of coagulopathy or thrombocytopenic purpura; 11. Vascular access infection or active systemic infection; 12. Surgically treated restenosis; 13. Those who had participated or were participating in clinical trials of other drugs or medical devices within three months before screening; 14. Patients with severe calcification (PACSS score: grade 4); 15. No outflow tract of target lesion below ankle joint; 16. It was considered by the investigator that the patient might not adhere to the trial protocol or had other conditions that precluded participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The target lesions were unobstructed 6 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Instrument success rate;Technical success rate;Major adverse event rates (including all-cause deaths, major amputations, and CD-TLRs);Primary patency rate of target lesions (12 months, 24 months);Rutherford grade and change from baseline (before discharge, 6 months, 12 months, 24 months);ABI and the change from preoperative baseline (before discharge, 6 months, 12 months, 24 months);All-cause mortality;Incidence of major amputation (amputation above the ankle);Incidence of target lesion revascularization (secondary intervention of target lesion from any cause, including open and interventional procedures);Incidence of target lesion restenosis (6 months, 12 months, 24 months);Incidence of device defects; | — |
Countries
China
Contacts
Public ContactGuo Lianrui
Xuanwu Hospital of Capital Medical University
Outcome results
None listed